Effect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstruction

NCT07306221 | Recruiting

• 1 other identifier: M20250822
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the improvement effect of visual-guided balance training on the knee joint function and gait performance of patients after ACLR, and to clarify the advantages of this training program compared to conventional rehabilitation training; at the same time, by including healthy individuals as the control group, it quantifies the differences in knee joint function and gait performance between patients after ACLR and healthy individuals, to verify whether visual-guided balance training can more effectively narrow the functional gap between patients after ACLR and healthy individuals, and promote the recovery of patients' knee joint function and gait closer to the healthy level. Ultimately, it provides scientific theoretical basis and practical guidance for the optimization of the rehabilitation plan after ACLR, and helps patients achieve comprehensive and high-quality recovery.

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior cruciate ligament injuries; Visual-guided balance training; gait; ACLR; reconstruction of anterior cruciate ligament

Outcome Measures

Primary Outcomes (7)

• Vicon 3D Gait Testing

  The subjects first underwent a static test, and then chose to perform tests of slow jogging, walking and single-leg balance at their own pace. Observe the three-dimensional plane joint angles（degree) of each joint in the lower limbs.

  Preoperative baseline; 14 weeks after the operation; 6 months after the operation

• Vicon 3D Gait Testing

  The subjects first underwent a static test, and then chose to perform tests of slow jogging, walking and single-leg balance at their own pace. Observe the three-dimensional plane joint torques (BW×BH）of each joint in the lower limbs.

  Preoperative baseline; 14 weeks after the operation; 6 months after the operation

• Vicon 3D Gait Testing

  After a static trial, participants performed self-paced tests of slow jogging, walking, and single-leg balance while three-dimensional ground reaction forces （BW)at each lower-limb joint were recorded.

  Preoperative baseline; 14 weeks after the operation; 6 months after the operation

• isokinetic muscle strength

  This isokinetic muscle strength test selected two angular velocities: 60°/second (slow speed) and 180°/second (medium speed). Observe the relative peak torque （ N·m/kg）of the quadriceps and hamstring muscles.

  Preoperative baseline;14 weeks after the operation; 6 months after the operation

• isokinetic muscle strength

  This isokinetic muscle strength test selected two angular velocities: 60°/second (slow speed) and 180°/second (medium speed).Observe the limb symmetry index（%） of the quadriceps and hamstring muscles.

  Preoperative baseline;14 weeks after the operation; 6 months after the operation

• isokinetic muscle strength

  This isokinetic muscle strength test selected two angular velocities: 60°/second (slow speed) and 180°/second (medium speed).Observe the hamstring-to-quadriceps peak-torque ratio (H/Q).

  Preoperative baseline;14 weeks after the operation; 6 months after the operation

• Imoove Balance Training Tester

  The dynamic balance ability of the subjects was evaluated. The main observations included the imbalance percentage, the score of the green target, coordination, stability, distribution balance, and the total score. The score ranged from 0 to 100, with a higher score being better.

  Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

Secondary Outcomes (5)

• Lysholm Knee Joint Scoring Scale

  Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

• International Knee Documentation Committee Knee Assessment Scale

  Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

• Visual Analogue Score

  Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

• Tampa Scale for Kinesiophobia-11

  Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

• ACL Return to Sport after Injury scale

  Preoperative baseline; 4 weeks after the operation; 14 weeks after the operation; 6 months after the operation

Study Arms (3)

Healthy control group

NO INTERVENTION

The main focus is on conducting a comparative analysis of health conditions based on the analysis of motor functions.

Traditional group

ACTIVE COMPARATOR

Based on the conventional standardized rehabilitation procedures, additional general balance training content is added.

Other: Traditional group

Intervention group

EXPERIMENTAL

Based on the conventional standardized rehabilitation program, add the content of visual-guided balance training

Other: Intervention Group

Interventions

Traditional group OTHER

Based on the traditional standardized rehabilitation program, additional universal balance training content has been added. Starting from the 5th week after the surgery and continuing until the 14th week, three times a week for a total of 10 weeks, the training duration was one and a half hours each time.

Traditional group

Intervention Group OTHER

Based on the conventional standardized rehabilitation program, add the content of visual-guided balance training.Starting from the 5th week after the surgery and continuing until the 14th week, three times a week for a total of 10 weeks, the training duration was one and a half hours each time.

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 45 years old;
• Body Mass Index (BMI) ranging from 18.5 kg/m² to less than 35 kg/m²;
• First unilateral ACL rupture and reconstruction surgery performed at this hospital;
• Autologous hamstring tendon transplantation;
• No or only minor injury to the meniscus, posterior cruciate ligament, medial collateral ligament or lateral collateral ligament;
• Voluntary participation in this study and signing of informed consent form.

You may not qualify if:

• Patients who underwent ACL reconstruction more than one year after the injury;
• Patients with severe injuries to the posterior cruciate ligament, medial collateral ligament or lateral collateral ligament (more than grade I; grade II is partial tear, thickening and tortuosity of the ligament, partial fiber interruption, and swelling of the surrounding soft tissues; grade III is complete rupture). ； Combined with severe meniscus tear;
• Has a history of previous knee surgery, such as meniscus repair, ligament reconstruction, joint replacement, joint cleaning, etc.;
• Has other knee joint diseases, such as: knee osteoarthritis, knee joint tumor, rheumatoid arthritis, tuberculosis, knee joint infection or inflammatory diseases, fracture, dislocation or other bone injuries, etc.;
• Severe heart, lung, brain diseases or liver and kidney dysfunction, and visual and cognitive impairments.
• Age 18-45 years old;
• Body Mass Index (BMI) ≥ 18.5 kg/m2 and \< 35 kg/m2;
• No surgical history, injury history, or chronic joint diseases of the lower extremities;
• No visual, cognitive impairments or neurological diseases;
• \. Poor compliance of the subject; 2. The subject withdraws the informed consent form; 3.The subject requests to terminate the study or is unable to complete all the trials for some reason; 4. The investigator believes that the subject's continued participation in the trial may cause significant adverse effects on their physical condition; 5. The ethics review committee decides to terminate the trial.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• ren shuang, doctor

  Be affiliated with the organization

  STUDY CHAIR

Central Study Contacts

ren shuang, doctor

CONTACT

17610252992; xixishuang123@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 29, 2025
• Study Start: November 22, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)